A coroner has said warnings within software applications designed to alert prescribing health professionals about the potential side effects of ofloxacin, including suicidal thoughts, do not adequately inform prescribers and patients about the risks.
In his report on the inquest into the death of Alexander Mulroney, who took his own life in December last year after taking the fluoroquinolone antibiotic, which is used to treat bacterial infections, the assistant coroner for Berkshire Ian Wade said the “current approach to publishing warnings of possible harm provides insufficient safeguards”.
The inquest heard Mulroney was “an intelligent and successful lawyer with a wife and children he loved in a secure relationship” and had “no history of emotional or mental ill-health”.
He was prescribed ofloxacin for a physical condition that caused urinary and genital symptoms after “a first-line antibiotic had not cured his illness”.
He took the medicine as prescribed from December 16, 2025. On the evening of December 17, 2025, he left his home in Reading in his pyjamas and a coat “asserting that he was in substantial discomfort because of a rash” and told his wife he was going to hospital, which the inquest heard was “untrue”.
In the early hours of December 18, 2025, he drove to a dual carriageway and stopped on the way to text his wife a message which expressed “sorrow for what he was about to do”.
Catastrophic injuries from which he died at the scene
“(He) deliberately drove his motor car at speed … in a failed attempt to end his life and immediately thereafter returned on foot to the highway … giving that vehicle no opportunity to avoid striking him,” the report said. “He suffered catastrophic injuries from which he died at the scene.”
Mulroney’s death was ruled a suicide. The report was sent to the Medicines and Healthcare products Regulatory Agency (MHRA), National Institute for Health and Care Excellence (NICE) and British National Formulary (BNF).
The report, which described ofloxacin as “a dangerous product, notwithstanding its benefits and widespread use”, said that “on the balance of probability, the prescribed ofloxacin” did not cause his death, although it “induced a determination to end his life”.
The report, which was also sent to Mulroney's next of kin, the prescribing GP and patient safety commissioner, said ofloxacin was “known to be associated with or give rise to a variety of harms or risk of harms to the patient”.
Those risks, it added, are “recognised by MHRA”, are “catalogued” in the BNF and within software applications which provide "on-screen alerts” when the drug is prescribed and are stated in patient information leaflets. The warnings, the report said, refer to possible physical as well as psychiatric harm and are “broadly referred to as side effects”.
However, the inquest heard evidence that warnings within software applications are “expressed as either ‘high severity warning’ (of which there is one) or ‘medium severity warnings’ (of which there are 12)”.
“The high severity warning refers in non-specific terms to ‘very rare reports of disabling and potentially long-lasting or irreversible side effects’ without mentioning suicide,” the report noted.
May lead to thoughts of suicide or suicide attempts
“The terms used would not ordinarily prompt consideration of death. The medium severity warnings begin with a reference to MHRA advising the use of ofloxacin with caution in psychiatric disorders can exacerbate existing symptoms which may lead to thoughts of suicide or suicide attempts.”
The inquest said that after “the recital of many other warnings comprising some 41 lines of dense and small print text, all relating to non-fatal outcomes”, there is a “twelfth warning”.
That warning states: “Alert – MHRA advises quinolones can cause psychiatric side effects including depression and psychosis which can lead to thoughts or attempts of suicide.”
Wade said he heard evidence that “in a typical time constrained doctor-patient consultation, the placing of an understated reference to the possibility of suicidal thoughts at the end of a relatively long and complex list of so-called medium severity alerts is missed, or is misleading, or is ineffective”.
Wade warned Mulroney’s suicide was “not the first such fatal outcome linked to such medication”.
In response to the report, NICE said the content of “prescribing information and how different risks are highlighted” in “external publications” were not matters for it to respond to.
“At NICE, we host the BNF on our website but we are not responsible for the content of the BNF,” NICE said, adding it “avoids duplicating safety advice in (its) guidance which is found elsewhere, namely the BNF and/or summary of product characteristics”.
“We updated relevant guidance in response to drug safety updates from the MHRA in 2023 and 2024, and would do so again should there be a further update from the MHRA,” NICE added.
MHRA noted concerns about risk of serious psychiatric adverse reactions
The BNF said it includes safety alerts issued by the MHRA “within important safety information sections of drug monographs”, which includes “patient and carer advice sections if a drug (or drug class) has a special need for counselling”.
The BNF also said the “side-effects sections” of its monographs “include information on side-effects that have been associated with the use of the drug or drug class”.
“This information is primarily based on licensed product information,” it added.
On warnings within software applications, the BNF said information supporting safe and effective prescribing of drugs such as ofloxacin is included in its content.
“Third party system developers may use this information to create a hierarchy of warnings within software applications used by health professionals. However, this is not determined by BNF,” it said.
The MHRA said it noted concerns about “the risk of serious psychiatric adverse reactions associated with fluoroquinolones, including ofloxacin, and the effectiveness of current risk communications”.
“We will therefore consider this matter further through the MHRA’s medicines safety review processes,” it added.
“As part of this review, we will consider whether the current regulatory and risk-minimisation measures remain appropriate and whether any further action is required to support the safe use of these medicines.”
